ID

29824

Description

Study of Hepatocellular Carcinoma in Cirrhotic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01904942

Link

https://clinicaltrials.gov/show/NCT01904942

Keywords

Versions (1)
  1. 4/22/18 4/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01904942

English

Eligibility Hepatocellular Carcinoma NCT01904942

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cases and controls will be males aged 35 or older, and will give an informed consent to participate in the study. all hcc cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. criteria for the diagnosis of hcc will be those defined by the european association for study of the liver (easl) (bruix j, j hepatol 2001): all patients with cirrhosis, whatever its etiology, will be included. the diagnosis of cirrhosis will rely on histological confirmation by liver biopsy:
Description

Gender | Age | Informed Consent | Liver carcinoma Evolving Liver Cirrhosis | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0332253
UMLS CUI [4,3]
C0023890
UMLS CUI [5]
C0193388
in patients free of portal thrombosis at doppler imaging, on the presence of portal hypertension ascertained by biological (tricytopenia), morphologic (abdominal us, ct or mri), hepatic venous pressure measurement or upper endoscopy (mosaic gastropathy, varices).
Description

Portal thrombosis Free of Doppler Ultrasound Imaging | Hypertension, Portal | Pancytopenia | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Hepatic venous pressure gradient | Endoscopy of stomach | Stomach Diseases | Gastric Varices

Data type

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C2713308
UMLS CUI [2]
C0020541
UMLS CUI [3]
C0030312
UMLS CUI [4]
C2348813
UMLS CUI [5]
C0412620
UMLS CUI [6]
C0412693
UMLS CUI [7]
C4049263
UMLS CUI [8]
C0017195
UMLS CUI [9]
C0038354
UMLS CUI [10]
C0017145
in patients with portal thrombosis, on the presence of portal hypertension associated with:
Description

Portal vein thrombosis | Hypertension, Portal

Data type

boolean

Alias
UMLS CUI [1]
C0155773
UMLS CUI [2]
C0020541
clinical (hepatomegaly with clinical evidence of hepatocellular failure: spider naevi, palmar erythema, white nails, gynecomastia) or morphological signs of cirrhosis (enlarged liver, nodular surface, sharp lower edge).
Description

Signs Liver Cirrhosis | Hepatomegaly | Failure Hepatocellular | Spider nevus | Palmar erythema | White nails | Gynecomastia | Signs morphological Liver Cirrhosis | Hepatomegaly | Surface Nodular | Liver edge Lower

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0023890
UMLS CUI [2]
C0019209
UMLS CUI [3,1]
C0231174
UMLS CUI [3,2]
C2697585
UMLS CUI [4]
C0085666
UMLS CUI [5]
C0014745
UMLS CUI [6]
C0423827
UMLS CUI [7]
C0018418
UMLS CUI [8,1]
C0311392
UMLS CUI [8,2]
C0543482
UMLS CUI [8,3]
C0023890
UMLS CUI [9]
C0019209
UMLS CUI [10,1]
C0205148
UMLS CUI [10,2]
C0205297
UMLS CUI [11,1]
C0426689
UMLS CUI [11,2]
C0441994
and/or biological signs of hepatocellular failure (tp<70%, low albuminemia)
Description

Signs Failure Hepatocellular | Total protein measurement | Blood albumin decreased

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0231174
UMLS CUI [1,3]
C2697585
UMLS CUI [2]
C0555903
UMLS CUI [3]
C0853777
and/or sinusoidal block assessed by liver venous gradient >18 mm hg in the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12,5 kpa without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral c hepatitis. the lack of hcc in cirrhotic patients at inclusion will be assessed through good quality imaging examinations (abdominal us, ct scan or mri) and afp below 100 ng/ml.
Description

Other Coding | Hepatic venous pressure gradient | FibroTest Score Measurement | Other Coding | Liver Cirrhosis | Hepatitis C, Chronic | Lack Liver carcinoma Imaging | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Alpha one fetoprotein measurement

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C4049263
UMLS CUI [3]
C3642160
UMLS CUI [4]
C3846158
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0524910
UMLS CUI [7,1]
C0332268
UMLS CUI [7,2]
C2239176
UMLS CUI [7,3]
C0011923
UMLS CUI [8]
C2348813
UMLS CUI [9]
C0412620
UMLS CUI [10]
C0412693
UMLS CUI [11]
C0201539
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
- patients under 35years old or more than 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
other cancer in evolution
Description

Cancer Other Developmental

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0458003
hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
major somatic or psychiatric illness not compatible with the inclusion in the study
Description

Illness Major Inconsistent Inclusion | Mental disorders Major Inconsistent Inclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0442809
UMLS CUI [1,4]
C1512693
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0442809
UMLS CUI [2,4]
C1512693
non hcc primary liver cancer.
Description

Liver carcinoma Primary Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0332197
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Similar models

Eligibility Hepatocellular Carcinoma NCT01904942

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Informed Consent | Liver carcinoma Evolving Liver Cirrhosis | Biopsy of liver
Item
cases and controls will be males aged 35 or older, and will give an informed consent to participate in the study. all hcc cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. criteria for the diagnosis of hcc will be those defined by the european association for study of the liver (easl) (bruix j, j hepatol 2001): all patients with cirrhosis, whatever its etiology, will be included. the diagnosis of cirrhosis will rely on histological confirmation by liver biopsy:
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C2239176 (UMLS CUI [4,1])
C0332253 (UMLS CUI [4,2])
C0023890 (UMLS CUI [4,3])
C0193388 (UMLS CUI [5])
Portal thrombosis Free of Doppler Ultrasound Imaging | Hypertension, Portal | Pancytopenia | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Hepatic venous pressure gradient | Endoscopy of stomach | Stomach Diseases | Gastric Varices
Item
in patients free of portal thrombosis at doppler imaging, on the presence of portal hypertension ascertained by biological (tricytopenia), morphologic (abdominal us, ct or mri), hepatic venous pressure measurement or upper endoscopy (mosaic gastropathy, varices).
boolean
C0155773 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C2713308 (UMLS CUI [1,3])
C0020541 (UMLS CUI [2])
C0030312 (UMLS CUI [3])
C2348813 (UMLS CUI [4])
C0412620 (UMLS CUI [5])
C0412693 (UMLS CUI [6])
C4049263 (UMLS CUI [7])
C0017195 (UMLS CUI [8])
C0038354 (UMLS CUI [9])
C0017145 (UMLS CUI [10])
Portal vein thrombosis | Hypertension, Portal
Item
in patients with portal thrombosis, on the presence of portal hypertension associated with:
boolean
C0155773 (UMLS CUI [1])
C0020541 (UMLS CUI [2])
Signs Liver Cirrhosis | Hepatomegaly | Failure Hepatocellular | Spider nevus | Palmar erythema | White nails | Gynecomastia | Signs morphological Liver Cirrhosis | Hepatomegaly | Surface Nodular | Liver edge Lower
Item
clinical (hepatomegaly with clinical evidence of hepatocellular failure: spider naevi, palmar erythema, white nails, gynecomastia) or morphological signs of cirrhosis (enlarged liver, nodular surface, sharp lower edge).
boolean
C0311392 (UMLS CUI [1,1])
C0023890 (UMLS CUI [1,2])
C0019209 (UMLS CUI [2])
C0231174 (UMLS CUI [3,1])
C2697585 (UMLS CUI [3,2])
C0085666 (UMLS CUI [4])
C0014745 (UMLS CUI [5])
C0423827 (UMLS CUI [6])
C0018418 (UMLS CUI [7])
C0311392 (UMLS CUI [8,1])
C0543482 (UMLS CUI [8,2])
C0023890 (UMLS CUI [8,3])
C0019209 (UMLS CUI [9])
C0205148 (UMLS CUI [10,1])
C0205297 (UMLS CUI [10,2])
C0426689 (UMLS CUI [11,1])
C0441994 (UMLS CUI [11,2])
Signs Failure Hepatocellular | Total protein measurement | Blood albumin decreased
Item
and/or biological signs of hepatocellular failure (tp<70%, low albuminemia)
boolean
C0311392 (UMLS CUI [1,1])
C0231174 (UMLS CUI [1,2])
C2697585 (UMLS CUI [1,3])
C0555903 (UMLS CUI [2])
C0853777 (UMLS CUI [3])
Other Coding | Hepatic venous pressure gradient | FibroTest Score Measurement | Other Coding | Liver Cirrhosis | Hepatitis C, Chronic | Lack Liver carcinoma Imaging | Abdominal Ultrasound | CT of abdomen | MRI of abdomen | Alpha one fetoprotein measurement
Item
and/or sinusoidal block assessed by liver venous gradient >18 mm hg in the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12,5 kpa without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral c hepatitis. the lack of hcc in cirrhotic patients at inclusion will be assessed through good quality imaging examinations (abdominal us, ct scan or mri) and afp below 100 ng/ml.
boolean
C3846158 (UMLS CUI [1])
C4049263 (UMLS CUI [2])
C3642160 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
C0332268 (UMLS CUI [7,1])
C2239176 (UMLS CUI [7,2])
C0011923 (UMLS CUI [7,3])
C2348813 (UMLS CUI [8])
C0412620 (UMLS CUI [9])
C0412693 (UMLS CUI [10])
C0201539 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Age
Item
- patients under 35years old or more than 75 years of age
boolean
C0001779 (UMLS CUI [1])
Cancer Other Developmental
Item
other cancer in evolution
boolean
C1707251 (UMLS CUI [1,1])
C0458003 (UMLS CUI [1,2])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Illness Major Inconsistent Inclusion | Mental disorders Major Inconsistent Inclusion
Item
major somatic or psychiatric illness not compatible with the inclusion in the study
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0442809 (UMLS CUI [2,3])
C1512693 (UMLS CUI [2,4])
Liver carcinoma Primary Absent
Item
non hcc primary liver cancer.
boolean
C2239176 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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